Central Drugs Standard Control Organisation (CDSCO) drug inspectors will soon get trained on relevant areas of GMP and cGMP through a specially designed customised online training courses, based on international regulatory guidelines.

As per the plan, CDSCO West Zone drug inspectors will get trained on critical and relevant areas including good manufacturing practices (GMP), good clinical practices (GCP), audit-readiness and remedial training. According to an official, "CDSCO inspectors across western region will be trained on what is essential in the inspection and standardisation process."

US based UL EduNeering, the compliance education and training services business division of UL Life and Health, will lead this initiative. UL offers about 1,200 courses globally and has trained around 38,000 US FDA inspectors till date.

UL also will build custom training modules for the CDSCO West Zone that suit the learning needs of their investigators. According to official sources, 10 investigators will be trained on 40 online modules in the first phase. UL has also signed up as a knowledge partner with the CDSCO West Zone.

CDSCO West Zone comprises the states of Maharashtra, Goa, Gujarat, Madhya Pradesh, Chhattisgarh and union territories of Daman & Diu and Silvassa. CDSCO works under the administrative control of India’s Drug Controller General of India (DCGI), Directorate General of Health Services (DGHS), ministry of health and family welfare (MoHFW).

Out of the 700 courses offered through e-learning mode, 150 courses were also made available in the past to Gujarat Food and Drug Control Authority (FDCA) state regulators on relevant areas of GMP, GDP and validation protocols. The training programme for CDSCO (West Zone) is a follow up of the MoU signed with the Gujarat government in the past on conducting online training in GMP and other relevant areas.

UL EduNeering is a leader in providing regulatory and compliance learning solutions to the life science industry. Its CFR 21 Part 11 validated platform is used globally by top pharma and medical device companies.

Last year, pharmaceutical exports from India to the United States rose 32 per cent to $4.2 billion. India accounts for about 40 per cent of generic and over the counter (OTC) products and 10 per cent of finished dosages used in the US.